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Non-invasive Hemoglobin Monitoring in Cesarean Section

Primary Purpose

Placenta Previa

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Masimo SpHb™ monitor

About this trial

This is an interventional diagnostic trial for Placenta Previa

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Pregnant woman
Elective Cesarean section
Placenta previa

Exclusion Criteria:

Decline of consent
Peripheral vascular disease
Cyanosis due to congenital heart disease
Refusal of transfusion
Mental retardation

Sites / Locations

Seoul National Univ. Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Placenta previa

Arm Description

Outcomes

Primary Outcome Measures

The change of total hemoglobin

Secondary Outcome Measures

The change of oxygen content

The change of methemoglobin

The change of carboxyhemoglobin

The change of pleth variability index

The change of perfusion index

Full Information

NCT ID

NCT03409822

First Posted

January 9, 2018

Last Updated

January 15, 2019

Sponsor

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03409822

Brief Title

Non-invasive Hemoglobin Monitoring in Cesarean Section

Official Title

The Effectiveness of Intraoperative Non-invasive Hemoglobin Monitoring in Parturients With Placenta Previa Undergoing Cesarean Section: Prospective Observational Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

February 5, 2018 (Actual)

Primary Completion Date

December 30, 2018 (Actual)

Study Completion Date

December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Non-invasive hemoglobin monitoring will be performed in patients who underwent cesarean section with placenta previa and this will be compared with actual laboratory findings. The investigators will investigate whether noninvasive hemoglobin monitoring can adequately reflect the massive bleeding that occurs within a short period of time and find out if it matches the actual laboratory findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Placenta Previa

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placenta previa

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Masimo SpHb™ monitor

Intervention Description

Attach the Masimo Rainbow SET® Radical-7 ™ pulse oximeter probe to the third or fourth finger and perform a Masimo SpHb ™ monitor.

Primary Outcome Measure Information:

Title

The change of total hemoglobin

Time Frame